This site is intended for healthcare professionals
Latest drug news
  • Home
  • /
  • News
  • /
  • 2016
  • /
  • 03
  • /
  • The FDA has rescheduled its advisory committee rev...
Drug news

The FDA has rescheduled its advisory committee review of Exondys (eteplirsen) to treat Duchenne muscular dystrophy to 25 April 2016- Sarepta

Read time: 1 mins
Last updated:12th Mar 2016
Published:12th Mar 2016
Source: Pharmawand

The FDA has rescheduled its advisory committee review of Exondys (eteplirsen), from Sarepta, to 25 April 2016.

Comment: Sarepta has been trying to persuade the FDA that dystrophin production is the surrogate marker that can be used to support approval of Exondys (eteplirsen) to treat Duchenne muscular dystrophy (DMD) but its data submitted of walking distance of boys taking the drug was from a small trial and rejected by the FDA. New data has been submitted. There is no treatment in the US for DMD.

 

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Related news and insights